United States 118th Congress Status: In Committee 1 D cosponsors

HR 1090 — DEVICE Act of 2023

Last action — Referred to the Subcommittee on Health.

  1. ✓
    Introduced
  2. 2
    In Committee
  3. 3
    Passed House
  4. 4
    Passed Senate
  5. 5
    To Executive
  6. 6
    Enacted

This bill died with 118th Congress. It reached “In Committee” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.

This bill is no longer active — its legislative session has ended, so there is no live prognosis. It would have to be reintroduced in the current session to move again.

Summary

To amend the Federal Food, Drug, and Cosmetic Act to enhance medical device communications and ensure device cleanliness.

Bill Text

How this bill changes current law

7 changes Share ↗

Compared against current U.S. Code AI-generated reading aid — verify against the official bill.

The bill introduces new reporting requirements for device manufacturers regarding design changes and communication with foreign health care providers, while also defining rapid assessment tests for reusable devices.

  • 21 U.S.C. 351

    (k) If it is a device with respect to which the manufacturer is in violation of the reporting requirement under section 510(r) (relating to design and reprocessing changes).

    Adds a new basis for adulteration related to violations of reporting requirements for design and reprocessing changes of devices.

  • 21 U.S.C. 360

    (r) Reporting Requirement for Device Design Changes.--Before making a change to the design of a device, or the reprocessing instructions of a device, that is marketed in interstate commerce, the manufacturer of the device shall give written notice of the change to the Secretary.

    Establishes a requirement for manufacturers to notify the Secretary of any design or reprocessing instruction changes before they are made.

  • 21 U.S.C. 351

    (l) If it is a device with respect to which the manufacturer is in violation of the reporting requirement under section 510(s) (relating to communications to foreign health care providers).

    Adds another basis for adulteration concerning violations of reporting requirements for communications with foreign health care providers.

  • 21 U.S.C. 360

    (s) Reporting Requirement for Certain Communications to Foreign Health Care Providers.--The manufacturer of a device that is marketed in interstate commerce shall give written notice to the Secretary of any communication described in paragraph (2) not more than 5 calendar days after making such communication.

    Mandates that manufacturers report specific communications about device design changes or safety concerns to foreign health care providers within 5 days.

  • 21 U.S.C. 321

    (D) a rapid assessment test intended to ensure the proper reprocessing of a reusable device (as defined in paragraph (ss)),

    Expands the definition of 'device' to include rapid assessment tests for ensuring proper reprocessing of reusable devices.

  • 21 U.S.C. 321

    (ss) The term `reusable device` means a device that--(1) is intended to be used more than one time; and (2) must be sanitized (whether through cleaning, disinfection, or sterilization) to ensure that the device is safe and effective for such intended use.

    Defines 'reusable device' specifically, clarifying the requirements for sanitization before reuse.

  • 21 U.S.C. 360

    (t) Instructions for Use and Validation Data.--(1) Initial list.--Not later than 1 year after the date of enactment of this subsection, the Secretary shall by regulation develop and publish a list of types of rapid assessment tests described in section 201(h)(1)(D) for which reports under subsection (k) must include--(A) instructions for use that have been validated in a manner specified by the Secretary; and (B) validation data, of the types specified by the Secretary.

    Requires the Secretary to create a list of types of rapid assessment tests that need specific validated instructions for use and validation data.

Action History

  1. Introduced in House

  2. Introduced in House

  3. Referred to the House Committee on Energy and Commerce.

  4. Referred to the Subcommittee on Health.

Sponsors

Sponsorship breakdown

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1 sponsors · 0 co-sponsors · 546 not signed on

Sponsors (1)

Co-sponsors (0)

None.

Not signed on (546)

546 members have not signed on to this bill.

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"Not signed on" means a member has not sponsored or co-sponsored this bill — it does not imply opposition. Members flagged Voted No have a recorded No vote on this bill.

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Subjects

healthcare technology
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Frequently asked questions

What does HR 1090 do?
To amend the Federal Food, Drug, and Cosmetic Act to enhance medical device communications and ensure device cleanliness.
Who sponsors HR 1090?
HR 1090 is sponsored by Lieu, Ted (Democratic).
What is the current status of HR 1090?
This bill died with 118th Congress. It reached “In Committee” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.
Where can I track HR 1090?
Track HR 1090 free on One Click Politics — get push/email alerts when it moves.

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